National Institute of Parasitic Diseases, Chinese Center for Disease Control and Prevention, Shanghai, People's Republic of China.
WHO Collaborating Center for Tropical Diseases, Shanghai, People's Republic of China.
Parasit Vectors. 2018 Jan 15;11(1):35. doi: 10.1186/s13071-018-2612-3.
Clonorchiasis ranks among the most important food-borne parasitic diseases in China. However, due to low compliance to traditional fecal examination techniques in the general population and medical personnel, immunodiagnosis is expected. This study evaluated, in parallel, the performance of four immunodiagnostic kits detecting clonorchiasis in China.
A bank with 475 sera was established in this study. Except for the low performance of the kit detecting IgM, the other three kits detecting IgG showed sensitivities ranging from 81.51% (194/238) to 99.16% (236/238). Higher sensitivity was presented in heavy infection intensity [89.47% (68/76) to 100% (76/76)]. Among the four kits, the overall specificity varied from 73.42% (174/237) to 87.34% (207/237). It was observed that the specificity was lower in the sera of the participants living in clonorchiasis-endemic areas but without any parasite infection [67.5% (81/120) to 90% (108/120)], as compared to those from the non-endemic area [94% (47/50) to 98% (49/50)]. The cross-reaction rate varied from 14.93% (10/67) to 31.34% (21/67). Youden's index was -0.022, 0.689, 0.726, and 0.802 for kits T1, T2, T3 and T4, respectively. Repeatability was high in all four kits.
Three immunodiagnosis kits targeting IgG antibody had high performance on detecting chronic Clonorchis sinensis infection, but that detecting IgM antibody had not. The kits detecting IgG antibody also showed high sensitivity in heavy infection intensity. Research on immunological diagnosis of clonorchiasis is expected to be strengthened to improve the sensitivity in light infection and specificity.
华支睾吸虫病是中国最重要的食源性寄生虫病之一。然而，由于普通人群和医务人员对传统粪便检查技术的依从性低，预计会采用免疫诊断。本研究平行评估了在中国用于检测华支睾吸虫病的四种免疫诊断试剂盒的性能。
本研究建立了一个包含 475 份血清的血清库。除了检测 IgM 的试剂盒性能较低外，其他三种检测 IgG 的试剂盒的敏感性范围为 81.51%（194/238）至 99.16%（236/238）。在重度感染强度下，灵敏度更高[89.47%（68/76）至 100%（76/76）]。在这四种试剂盒中，总特异性范围为 73.42%（174/237）至 87.34%（207/237）。观察到，来自华支睾吸虫病流行地区但无寄生虫感染的参与者的血清中，特异性较低[67.5%（81/120）至 90%（108/120）]，而非流行地区的特异性较高[94%（47/50）至 98%（49/50）]。交叉反应率范围为 14.93%（10/67）至 31.34%（21/67）。试剂盒 T1、T2、T3 和 T4 的约登指数分别为-0.022、0.689、0.726 和 0.802。所有四种试剂盒的重复性均较高。
针对 IgG 抗体的三种免疫诊断试剂盒在检测慢性华支睾吸虫感染方面具有较高的性能，但检测 IgM 抗体的试剂盒性能不佳。检测 IgG 抗体的试剂盒在重度感染强度下也具有较高的灵敏度。预计将加强对华支睾吸虫病免疫诊断的研究，以提高轻度感染的灵敏度和特异性。
